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Oral PCSK9 Pill Enlicitide Cuts LDL Up to 60% in Phase 3 Trial

The findings were presented as preliminary AHA meeting data, with a dedicated outcomes study still underway to determine effects on heart attacks and strokes.

Having high cholesterol in the blood can lead to a buildup called “plaque” on the walls of the arteries, raising the risk of cardiovascular disease.
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Overview

  • Phase 3 CORALreef Lipids enrolled 2,912 adults across 14 countries and randomized participants 2:1 to enlicitide 20 mg daily or placebo on top of mostly statin therapy.
  • LDL cholesterol fell by about 57% to nearly 60% at 24 weeks and remained reduced by roughly 51% to 53% at 52 weeks compared with placebo.
  • Enlicitide also reduced non-HDL by 53%, apolipoprotein B by 50%, and lipoprotein(a) by 28% in the 24-week analysis.
  • Serious adverse events occurred in about 10% with enlicitide versus 12% with placebo, with low discontinuation rates and no dominant safety signal reported.
  • Investigators reported lipid changes comparable to injectable PCSK9 antibodies and numerically greater than inclisiran, and Merck plans to seek FDA approval in early 2026 while the outcomes trial continues.